NDA 050634

TELIGENT

FDA Drug Application

Application #050634

Documents

• Letter: 2004-05-26
• Label: 2002-03-29
• Letter: 2002-03-29
• Letter: 2002-03-22
• Letter: 2007-03-15
• Letter: 2007-07-16
• Letter: 2014-09-26
• Label: 2004-05-27
• Label: 2007-03-15
• Label: 2007-07-10
• Label: 2014-09-26
• Label: 2017-07-31
• Letter: 2017-08-02

Application Sponsors

NDA 050634

TELIGENT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM
002	INJECTABLE;INJECTION	EQ 20MG BASE/ML	1	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM
003	INJECTABLE;INJECTION	EQ 40MG BASE/ML	1	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-03-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	1993-11-08
LABELING; Labeling	SUPPL	4	AP	1994-10-20
LABELING; Labeling	SUPPL	5	AP	1996-08-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	1998-01-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	1996-06-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	1996-06-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	1996-09-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	1996-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-11-25	STANDARD
LABELING; Labeling	SUPPL	12	AP	2002-03-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-02-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2004-05-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-03-14	STANDARD
LABELING; Labeling	SUPPL	20	AP	2007-07-09	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-04-11	STANDARD
LABELING; Labeling	SUPPL	28	AP	2017-07-28	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL	2	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	9
SUPPL	23	Null	6
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	15

CDER Filings

TELIGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50634
            [companyName] => TELIGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FORTAZ IN PLASTIC CONTAINER","activeIngredients":"CEFTAZIDIME SODIUM","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FORTAZ IN PLASTIC CONTAINER","activeIngredients":"CEFTAZIDIME SODIUM","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FORTAZ IN PLASTIC CONTAINER","activeIngredients":"CEFTAZIDIME SODIUM","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/28\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050578s061,050634s028lbl.pdf\"}]","notes":"Please see"},{"actionDate":"07\/28\/2017","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050578s061,050634s028lbl.pdf\"}]","notes":"Please see"},{"actionDate":"09\/24\/2014","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050578s055,050634s023lbledt.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050578s055,050634s023lbledt.pdf\"}]","notes":""},{"actionDate":"07\/09\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050578s053,050634s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2007","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050578s051,050634s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2004","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50578slr046,50634slr016_fortaz_lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2002","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50578s40lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FORTAZ IN PLASTIC CONTAINER","submission":"CEFTAZIDIME SODIUM","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FORTAZ IN PLASTIC CONTAINER","submission":"CEFTAZIDIME SODIUM","actionType":"EQ 20MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FORTAZ IN PLASTIC CONTAINER","submission":"CEFTAZIDIME SODIUM","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-28
        )

)